Genotoxicity and Carcinogenicity Testing of Pharmaceuticals

November 13, 2015|
Genotoxicity and Carcinogenicity Testing of Pharmaceuticals by Michael J. Graziano
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This book provides an overview of the nonclinical testing strategies that are used to asses and de-risk the genotoxicity and carcinogenicity properties of human pharmaceuticals. It includes a review of relevant ICH guidelines, numerous case studies where follow-up studies were conducted to further investigate positive findings, and practical considerations for the use of alternative and emerging tests.

With contributions from recognized experts in the pharmaceutical industry and health authorities, this volume presents a balanced view on the interpretation and application of genotoxicity and carcinogenicity regulatory guidances.  

Genotoxicity and Carcinogenicity Testing of Pharmaceuticalsis a valuable resource for scientists, regulators, and consultants that are engaged in the conduct, reporting, and review of nonclinical studies. This book will also help academicians better understand and appreciate the complexity of the regulations and breadth of toxicology research that are necessary to support the development and marketing of new drugs. 

Michael J. Graziano, Ph.D., has more than 27 years of experience as a toxicologist in the pharmaceutical industry. He is currently Vice President of Drug Safety Evaluation at Bristol-Myers Squibb, where he is responsible for the nonclinical safety testing for all drugs within the BMS portfolio. Within the past 6 years, he has...
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Title:Genotoxicity and Carcinogenicity Testing of Pharmaceuticals
Format:Paperback
Product dimensions:206 pages, 9.25 X 6.1 X 0 in
Shipping dimensions:206 pages, 9.25 X 6.1 X 0 in
Published:November 13, 2015
Publisher:Springer-Verlag/Sci-Tech/Trade
Language:English
Appropriate for ages:All ages
ISBN - 13:9783319220833

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